A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer

Inclusion Criteria:

- Be female and at least 18 years of age (or minimum legal age and competency to
provide voluntary written informed consent for study participation);

- Histologically/cytologically confirmed epithelial ovarian cancer that meets one of
the following criteria:

- measurable disease by computed tomography (CT) scan or

- malignant ascites, or

- Serum CA-125 levels; or

- Clinically evaluable recurrent disease by other criteria.

- Relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6
months since last exposure to platinum based therapy).

- Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1 or 2;

- Recovered from prior chemotherapy, having adequate bone marrow function:

- Adequate renal function;

- Adequate liver function;

- If of childbearing potential, have a negative pregnancy test and agree to follow an
acceptable method of birth control;

- Agree to be compliant with the study's requirements;

- Understand and sign a written Informed Consent prior to the performance of any
study-related procedures.

Exclusion Criteria:

- Ovarian cancer other than documented epithelial cancer;

- Intra-abdominal disease > 5 cm in diameter;

- Any serious, uncontrolled, intercurrent medical illness or disorder including, but
not limited to:

- Autoimmune disorders

- Cardiac Disorders

- Diabetes

- Intrahepatic disease/cancer as documented by CT-scan

- An active infection within 4 weeks of study entry;

- Any condition/anomaly that would interfere with the appropriate placement of the IP
catheter for study drug administration

- Prior treatment with whole abdominal irradiation;

- Currently receiving or have received any investigational agents within 28 days of
study entry;

- Received prior chemotherapy for ovarian cancer administered by the IP route;

- Received any chemotherapy between completion of primary chemotherapy for ovarian
cancer and study entry (e.g. consolidation therapy);

- Receipt of immunotherapy and/or any medications with the potential to affect the
activity of EGEN 001;

- Known history of HIV infection, hepatitis B, or hepatitis C;

- Known hypersensitivity to any of the components of carboplatin or docetaxel;

- Life expectancy of less than 3 months;

- Known, current, recreational drug or alcohol abuse;

- Breast feeding an infant;

- Psychiatric illness/social situations which would limit compliance with study
requirements;

- Any other known condition which in the Investigator's opinion would make the patient
a poor candidate for the study.